| Objective:To observe the effect and safety of Du-huo-ji-sheng Decoction in the treatment of bone metastasis of postmenopausal Luminal breast cancer with deficiency of Liver and Kidney Yin,and to provide evidence for the treatment of bone metastasis of postmenopausal Luminal breast cancer with deficiency of Liver and Kidney Yin by integrated Traditional Chinese medicine and Western medicine.Method:60 cases of bone metastasis of postmenopausal Luminal breast cancer with deficiency of Liver and Kidney Yin were randomly divided into control group and observation group,with 30 patients in each group.The control group was given aromatase inhibitor,bisphosphonate,calcium and vitamin D;Observation group was combined with Du-huo-ji-sheng Decoction on the basis of control group.The treatment period of both groups was 2 months.Clinical score of symptoms of Traditional Chinese Medicine(TCM),Karnofsky Performance Status(KPS),NRS pain score,blood calcium and estradiol were observed before and after treatment in 2 groups,and the clinical effects and safety of Du-huo-ji-sheng Decoction were calculated comprehensively.Results:Before the study,there was no statistical significance in age,bone metastasis site,breast cancer type,endocrine drugs and bisphosphonates type,blood calcium,KPS,NRS pain score,total score and individual score of clinical score of TCM symptoms,and estradiol level between the two groups(P>0.05).After treatment,the changes of the observed indicators were as follows:1.KPS :The KPS was higher after treatment than before in both groups(P<0.05),and the observation group’KPS was higher than that in the control group(P<0.05).2.Clinical score of TCM symptoms:The total score of TCM symptoms in both groups decreased after treatment compared with before treatment(P<0.05).In the control group,the symptoms scores of physical pain,soreness of waist and knee,fatigue,lack of appetite,amnesia and insomnia and limb weakness were decreased compared with those before treatment(P<0.05).The symptoms scores of the observation group,such as body pain,soreness of waist and knee,fatigue,lack of appetite,insomnia and forgetfulness,hot flashes and night sweats,tinnitus,limb weakness and dizziness were significantly decreased compared with those before treatment(P<0.05).The total scores and individual scores were compared between the two groups after treatment.The total scores of the observation group decreased increasingly than that of the control group(P<0.05).The improvement of body pain,soreness of waist and knee,fatigue,tinnitus in the combined TCM group was better than that in the control group(P<0.05).3.NRS pain score: After treatment,NRS score in both groups was increasingly lower than that before treatment(P<0.05).Comparison between groups showed that pain relief in the combined TCM group was better(P<0.05).4.Blood calcium: After treatment,blood calcium in both groups was lower than before treatment(P<0.05).Comparison between groups showed that there was no significant difference in both groups.5.TCM clinical efficacy: In the conventional control group,0 cases were clinically cured,1 case was significantly effective,9 cases were effective and 20 cases were ineffective after treatment;In the TCM observation group,1 case was cured,2 cases were effective,16 cases were effective and 11 cases were ineffective.Rank sum test was used,Z=-2.346,P<0.05,which was statistically significant.6.Safety indicators: There were no statistically significant differences in estradiol levels between the two groups after treatment(P>0.05).In addition,no abnormal blood routine,liver and kidney function,local recurrence and distant metastasis of breast cancer occurred in the two groups during the study.Conclusion: Du-huo-ji-sheng Decoction can improve the physical condition of patients for bone metastasis of postmenopausal Luminal breast cancer with deficiency of Liver and Kidney Yin,reduce physical pain,improve the clinical symptoms such as waist and knee soreness,fatigue and tinnitus,and improve the quality of life.At the same time,Du-huo-ji-sheng Decoction has no statistical significance in the change of estrogen level in vivo,so it is safe and reliable. |
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